Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
Recruiting
N/AInterventional Study
Bone RegenerationSafety Issues
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
96 (estimated)
Sponsor
Wishbone SA · Industry
Who this trial is looking for
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This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* The subject signed the informed consent form;
* The subject is ≥ 18 and ≤ 80 years old at surgery;
* The subject is in need of a tooth extraction prior to implant placement;
* All four bony walls are preserved after extraction;
* Minimum 8mm height of bone;
* Minimum 7mm thick…
Inclusion Criteria:
* The subject signed the informed consent form;
* The subject is ≥ 18 and ≤ 80 years old at surgery;
* The subject is in need of a tooth extraction prior to implant placement;
* All four bony walls are preserved after extraction;
* Minimum 8mm height of bone;
* Minimum 7mm thickness of lingual vestibular;
* The subject is willing and able to comply with all investigation related procedures (such as exercising oral hygiene and attending all follow-up visits);
* Full-mouth bleeding score (FMBS) lower than 25%;
* Full-mouth plaque score (FMPI) lower than 25%.
Exclusion Criteria:
* Subject with an acute infection (abscess) at the surgical site;
* Subject with untreated periodontitis or periodontal disease;
* Subject with autoimmune diseases or subjects that had received or were currently receiving treatment with antiresorptive drugs (e.g., bisphosphonates), or steroid therapy;
* Subject who is pregnant or breastfeeding;
* Subjects is a heavy smoker (\>10 cigarettes a day);
* Subject with an inability to conduct basic oral hygiene (poor oral hygiene and motivation);
* Subject with metabolic diseases (diabetes, hyperparathyroidism, osteomalacia);
* Subject with severe renal dysfunction and severe liver disease;
* Subject with known severe osteoporosis;
* Subject with multiple sclerosis and/or acromegaly;
* Subject follows radiotherapy;
* Subject with psychiatric disorders or under substance abuse (drug or alcohol);
* Subject who participates in other clinical trials interfering with the present protocol;
* Mucosal diseases in the areas to be treated.
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